| June 2, 2010 |
Archive for the ‘Uncategorized’ category
MedImmune FDA advisory Committee for motavizumab
April 15th, 2010Medimmune LLC meets with FDA Antiviral Committee for motavizumab
May 26th, 2010| June 2, 2010 |
Delcath and ArQule Releases Non-Public data at ASCO 12:00 PM June 5, 2009
May 26th, 2010| June 5, 2010 |
http://abstract.asco.org/AbstView_74_53424.html
Novartis Pharmaceuticals FDA adviosry meeting for GILENIA
April 15th, 2010| June 10, 2010 |
Novartis Meets with the Peripheral and Central Nervous System Drugs Advisory Committee to discuss GILENIA
May 26th, 2010| June 10, 2010 |
The committee will discuss new drug application (NDA) 22-527, with the proposed trade name GILENIA (fingolimod hydrochloride) 0.5 milligram (mg) capsules, by Novartis Pharmaceuticals Corporation. The proposed indication for this new drug product is treatment of relapsing forms of multiple sclerosis.
Laboratoire HRA Pharma meets with Reproductive Health Drugs Advisory Committee to discuss ulipristal acetate tablets
May 26th, 2010| June 17, 2010 |
The committee will discuss new drug application (NDA) 22-474, ulipristal acetate tablets, 30 milligrams (mg), by Laboratoire HRA Pharma. Ulipristal is an emergency contraceptive for the proposed indication of the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
Genzyme (GENZ): Lumizyme PDUFA date, June 17, 2010
April 21st, 2010| June 17, 2010 |
Boehringer Ingelheim Pharmaceuticals meets with the Reproductive Health Drugs Advisory Committee to discuss flibanserin tablets
May 26th, 2010| June 18, 2010 |
The committee will discuss new drug application (NDA) 22-526, flibanserin 100 milligram (mg) tablets, by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
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